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FDA 510(k)

RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS

K-Number: K991319 · 1999-09-21

ApplicantOrfit Industries
Decision Date1999-09-21
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS is the device name listed in this FDA 510(k) record. The listed applicant is Orfit Industries. It received FDA 510(k) clearance on 1999-09-21 under 510(k) number K991319. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS?

RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS is a medical device that received FDA 510(k) clearance on 1999-09-21. The listed applicant is Orfit Industries. The 510(k) number is K991319.

When did RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS receive FDA 510(k) clearance?

RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS received FDA 510(k) clearance on 1999-09-21, under 510(k) number K991319.

Who is the listed applicant for RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS?

The FDA 510(k) record lists Orfit Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS?

The FDA product code for RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS is IYE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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